U.S. patent number 11,083,488 [Application Number 15/531,435] was granted by the patent office on 2021-08-10 for insertion guide.
This patent grant is currently assigned to XACT ROBOTICS LTD.. The grantee listed for this patent is XACT ROBOTICS LTD.. Invention is credited to Ofer Arnold, Ben Galili, Daniel Glozman, Simon Sharon.
United States Patent |
11,083,488 |
Galili , et al. |
August 10, 2021 |
Insertion guide
Abstract
A device for insertion of a flexible needle or other such
instrument into a tissue, incorporating a collapsible support guide
which supports that part of the needle which has not yet penetrated
the tissue, preventing it from buckling, and an arrangement which
pulls the needle from its proximal end to provide sufficient force
for the penetration process. The collapsible support guide can be a
pair of flexible strips connected along their length and enclosing
the needle along its uninserted length in order to support it, with
a mechanism at the distal end of the device to peel the strips from
the needle as it is inserted. Insertion can be achieved by a pair
of rollers engaging and advancing the strips distally.
Alternatively, a telescopic support tube can be used to support the
needle, the tube collapsing telescopically as the needle is
inserted, to maintain clearance above the needle.
Inventors: |
Galili; Ben (Haifa,
IL), Arnold; Ofer (Ma'ale Tzviya, IL),
Sharon; Simon (Hof Carmel, IL), Glozman; Daniel
(Kfar Adumim, IL) |
Applicant: |
Name |
City |
State |
Country |
Type |
XACT ROBOTICS LTD. |
Caesarea |
N/A |
IL |
|
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Assignee: |
XACT ROBOTICS LTD. (Caesarea,
IL)
|
Family
ID: |
56073735 |
Appl.
No.: |
15/531,435 |
Filed: |
November 28, 2015 |
PCT
Filed: |
November 28, 2015 |
PCT No.: |
PCT/IL2015/051158 |
371(c)(1),(2),(4) Date: |
May 28, 2017 |
PCT
Pub. No.: |
WO2016/084092 |
PCT
Pub. Date: |
June 02, 2016 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20170258489 A1 |
Sep 14, 2017 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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62085518 |
Nov 29, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
34/20 (20160201); A61B 10/04 (20130101); A61M
25/0113 (20130101); A61B 17/3403 (20130101); A61M
39/02 (20130101); A61N 1/372 (20130101); A61B
2010/045 (20130101); A61B 2034/2055 (20160201); A61B
2017/00991 (20130101); A61B 2017/3409 (20130101); A61M
2025/0166 (20130101); A61M 2025/0008 (20130101); A61B
2034/2059 (20160201) |
Current International
Class: |
A61B
17/34 (20060101); A61M 25/01 (20060101); A61B
10/04 (20060101); A61B 34/20 (20160101); A61M
39/02 (20060101); A61M 25/00 (20060101); A61N
1/372 (20060101); A61B 17/00 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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20309019 |
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Jul 2013 |
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CN |
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203662950 |
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Jun 2014 |
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CN |
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983021 |
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Mar 2000 |
|
EP |
|
98/49943 |
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Dec 1998 |
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WO |
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2014098766 |
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Jun 2014 |
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WO |
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2015/052719 |
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Apr 2015 |
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WO |
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Other References
Supplementary European Search Report in corresponding European
Application No. 15862947.7 dated Jun. 29, 2018. cited by applicant
.
Translation of Office Action dated Oct. 29, 2019, in correspnding
Japanese Application No. 2017-528175. cited by applicant .
Translation of Office Action dated Mar. 3, 2020 in corresponding
Chinese Application No. 2015800749427. cited by applicant .
PCT Search Report for International Application No.
PCT/IL2015/051158 dated Mar. 27, 2016, 5 pp. cited by applicant
.
PCT Written Opinion for International Application No.
PCT/IL2015/051158 dated Mar. 27, 2016, 5 pp. cited by applicant
.
PCT Preliminary Report on Patentability for International
Application No. PCT/IL2015/051158 dated May 30, 2017, 6 pp. cited
by applicant.
|
Primary Examiner: Stigell; Theodore J
Attorney, Agent or Firm: The Roy Gross Law Firm, LLC Gross;
Roy
Claims
The invention claimed is:
1. An insertion device for insertion of a medical tool towards a
target in a body of a subject, the insertion device comprising: two
flexible strips connected to each other along at least a portion of
their lengths and having a central channel therebetween configured
to receive the medical tool; and two rollers disposed on opposite
sides of the connected two flexible strips; wherein the connected
two flexible strips and the medical tool are configured to be
secured together at an end remote from the two rollers, upon the
medical tool being received within the central channel, such that
counter-rotation of the two rollers, in an appropriate direction,
moves the connected two flexible strips towards the two rollers,
resulting in advancement of the medical tool towards the target;
and wherein the insertion device comprises two separate units
configured to be connected to and disconnected from each other,
each unit comprising one flexible strip of the two flexible strips
and one roller of the two rollers.
2. An insertion device according to claim 1, wherein each roller of
the two rollers comprises a plurality of protrusions arranged along
its circumference, the plurality of protrusions being configured to
engage with corresponding plurality of holes formed along the
length of each flexible strip of the two flexible strips.
3. An insertion device according to claim 2, wherein the distance
between two adjacent protrusions of the plurality of protrusions is
larger than the distance between two adjacent holes of the
plurality of holes.
4. An insertion device according to claim 1, wherein the two
flexible strips are connected to each other on at least one side of
the central channel, and are not connected to each other in a
region of the central channel.
5. An insertion device according to claim 1, further comprising a
holder member configured to secure together the connected two
flexible strips and the medical tool at the end remote from the two
rollers.
6. An insertion device according to claim 1, further comprising a
guide member comprising: one or more cavities configured to
accommodate the two rollers; and an opening configured to allow
passage of the medical tool therethrough.
7. An insertion device according to claim 6, wherein the opening
comprises a constraining mechanism configured to be adjusted
according to the dimensions of the medical tool, at least a portion
of the constraining mechanism being disposed within the opening,
wherein the constraining mechanism comprises at least two portions
disposed opposite each other, and wherein at least one of the at
least two portions is adapted to be moved towards another of the at
least two portions.
8. An insertion device according to claim 1, further comprising a
separating feature configured to direct each flexible strip of the
two flexible strips around a roller of the two rollers, wherein the
separating feature comprises at least one of: (a) unconnected
distal ends of the two flexible strips, each of the unconnected
distal ends being wound around an associated roller of the two
rollers, and (b) two structural edges, each flexible strip of the
two flexible strips being directed by a structural edge of the two
structural edges around an associated roller of the two
rollers.
9. An insertion device according to claim 1, wherein the central
channel includes weakened sections along its length to facilitate
winding of each flexible strip of the two flexibles strip around a
roller of the two rollers.
10. An insertion device according to claim 1, wherein the medical
tool comprises a tip, and the insertion device further comprises a
protecting element configured to prevent the tip from contacting an
internal surface of the central channel as the medical tool is
advanced in the direction of the target.
11. An insertion device according to claim 1, further comprising an
encoder configured to determine the position of the medical
tool.
12. An insertion device according to claim 1, wherein the medical
tool comprises one or more of: a needle, a cannula, a catheter, an
introducer, a port, a fluid delivery tube or an electrode rod.
13. An insertion device according to claim 1, wherein each roller
of the two rollers comprises two rollers assembled on a single
shaft.
14. An insertion system for insertion of a medical tool towards a
target in a body of a subject, the insertion system comprising: an
insertion device comprising: two flexible strips connected to each
other along at least a portion of their lengths and having a
central channel therebetween configured to receive the medical
tool; and two rollers disposed on opposite sides of the connected
two flexible strips; wherein the connected two flexible strips and
the medical tool are configured to be secured together at an end
remote from the two rollers, upon the medical tool being received
within the central channel, such that counter-rotation of the two
rollers, in an appropriate direction, moves the connected two
flexible strips towards the two rollers, resulting in advancement
of the medical tool towards an insertion target; a housing
configured to receive the insertion device; a locking mechanism
configured to lock the insertion device within the housing; and an
actuation mechanism configured to counter-rotate the two rollers,
the actuation mechanism comprising at least one motor and at least
one gear.
15. An insertion system according to claim 14, wherein a first
portion of the actuation mechanism is coupled to the housing, and a
second portion of the actuation mechanism is coupled to a guide
member of the insertion device.
16. An insertion system according to claim 14, wherein the locking
mechanism comprises: a rotating member coupled to the insertion
device; and one or more slits formed in the housing; wherein
rotation of the rotating member such that at least a portion of the
rotating member enters at least one of the one or more slits locks
the insertion device within the housing.
17. An insertion system according claim 14, further comprising: a
front leading element coupled to the insertion device; and a back
leading element coupled to the housing; wherein the front and back
leading elements are configured to receive therebetween an
unconnected end of a flexible strip of the two flexible strips
after the unconnected end is wound around a roller of the two
rollers.
18. An insertion system according to claim 14, wherein each roller
of the two rollers comprises a plurality of protrusions arranged
along its circumference, the plurality of protrusions being
configured to engage with corresponding plurality of holes formed
along the length of each flexible strip of the two flexible
strips.
19. An insertion system according to claim 14, wherein the medical
tool comprises one or more of: a needle, a cannula, a catheter, an
introducer, a port, a fluid delivery tube or an electrode rod.
20. An insertion device for insertion of a medical tool towards a
target in a body of a subject, the insertion device comprising: two
flexible strips connected to each other along at least a portion of
their lengths and having a central channel therebetween configured
to receive the medical tool; two rollers disposed on opposite sides
of the connected two flexible strips; a guide member comprising:
one or more cavities configured to accommodate the two rollers; an
opening configured to allow passage of the medical tool
therethrough; and a constraining mechanism configured to be
adjusted according to the dimensions of the medical tool, the
constraining mechanism being at least partially disposed within the
opening, wherein the connected two flexible strips and the medical
tool are configured to be secured together at an end remote from
the two rollers, upon the medical tool being received within the
central channel, such that counter-rotation of the two rollers, in
an appropriate direction, moves the connected two flexible strips
towards the two rollers, resulting in advancement of the medical
tool towards the target.
Description
FIELD OF THE INVENTION
The present invention relates to the field of insertion of needles
and other thin medical tools, and especially to devices for
preventing the medical tool from buckling during insertion.
BACKGROUND
Many routine treatments employed in modern clinical practice
involve percutaneous insertion of needles, catheters and other thin
medical tools, for biopsy, drug delivery and other diagnostic and
therapeutic procedures. The aim of an insertion procedure is to
place the tip of an appropriate medical instrument safely and
accurately in a target region, which could be a tumor, lesion,
organ or vessel. Examples of treatments requiring insertion of a
needle, or another similar medical tool, include vaccinations,
blood/fluid sampling, regional anesthesia, tissue biopsy, catheter
insertion, cryogenic ablation, electrolytic ablation,
brachytherapy, neurosurgery, deep brain stimulation and various
minimally invasive surgeries.
Such medical tools (e.g., needles) are generally thin walled, of
small diameter and mostly very long. Due to these characteristics,
and because of the force needed to penetrate the patient's skin
(approx. 10 N), it may be difficult to cause the needle to
penetrate the patient's skin from the proximal end of the needle
without the needle buckling under the force. The same problem may
apply should the needle encounter a hard object in its travel, such
as a bone.
In co-pending PCT application number PCT/IL2014/050891, for "Needle
Steering by Shaft Manipulation" having a common inventor with the
present application, there is described a device for the insertion
of a needle into a patient, in which the needle is held remotely
from its proximal end and pulled via a friction based mechanism.
Such a device may prevent buckling, but it is complex in
construction, and does not easily enable the use of disposable
sterilized needle packs. Furthermore, pulling the needle from its
proximal end by means of a friction drive may not provide
sufficient force to overcome the penetration forces described
hereinabove.
A friction drive generally requires applying radial forces on the
needle, which could cause the needle to yield. As the trend in
biopsy needles is for reduction of the needle wall thickness, this
could become a significant issue.
In U.S. Pat. No. 7,822,458 to R. J. Webster III et al, for "Distal
Bevel Tip Needle Control Device and Algorithm", there is described
a method of percutaneously steering a surgical needle into a
patient's tissue. One embodiment shows a pair of drive wheels
pulling the needle into the patient's skin from its distal end,
this embodiment having the same disadvantages as that of
PCT/IL2014/050891. A second embodiment uses a telescopic guide, but
has the disadvantage that because of the lead screw used in order
to advance the needle, the height of the mechanism is maintained at
its fixed full dimension, which hinders its use, for instance,
within the limited bore of a CT system.
There therefore exists a need for a new insertion device, which
overcomes disadvantages of prior art devices.
The disclosures of each of the publications mentioned in this
section and in other sections of the specification, are hereby
incorporated by reference, each in its entirety.
SUMMARY OF THE INVENTION
The present disclosure describes methods and apparatus for the
mechanical insertion of a flexible needle or any other thin long
instrument or object, into soft medium (e.g., tissue) by use of a
collapsible support guide which supports that part of the needle
which has not yet penetrated the medium, preventing it from
buckling, yet does not impede the continuous insertion process.
Different implementations of the devices described in this
disclosure include:
(i) use of a flexible support guide, such as a pair of flexible
strips connected along their length and enclosing the needle along
at least a part of the needle's length. The strips are adapted to
peel away from the needle as it is inserted, and this enables the
needle to be inserted by advancing it from its proximal end in
order to ensure that sufficient force can be applied for the
penetration process; (ii) use of a telescopic support tube which
supports the needle and prevents that part of it outside of the
patient's skin from buckling, and yet which collapses
telescopically as the needle is inserted such that the height of
the device does not impede use in limited spaces such as the bore
of a CT system.
For the first implementation (i) described herewithin using a
flexible support guide, a number of propulsion methods can be used
in order to push or pull the needle-support guide assembly by its
proximal end, into the patient's body, as follows:
(a) The proximal end of the guide is pulled down via a pulling
mechanism, such as by cables or straps;
(b) The guide itself is perforated and two or more rollers in the
lower part of the assembly have protrusions that engage the
perforations of the guide and pull the guide itself distally toward
the patient's body.
(c) The guide is shaped like a rack with teeth throughout at least
part of its length, and its teeth mesh with corresponding gear
teeth positioned at the lower part of the assembly.
(d) A friction based mechanism, in which the guides have a coarse
outer surface and a pair of oppositely facing pulleys are pressed
against them. The pulleys themselves may also be coarse.
(e) An array of piezo-electric drivers are mounted on one or more
sides of the needle or the guide, such that their drive elements
make contact with the needle or the guide respectively, and their
activation propels the needle or guide distally.
For the second implementation (ii) described herewithin, the
preferred propulsion method is by use of a cable distally pulling
the proximal end of the telescopic assembly with its encased
needle.
There is thus provided in accordance with an exemplary
implementation of the devices described in this disclosure, a
device for insertion of a tool, comprising:
(i) a guide member having an opening adapted to allow passage of
the tool therethrough,
(ii) a propulsion mechanism configured to advance the tool through
the opening in the direction of an insertion site, and
(iii) a buckling prevention mechanism configured to support the
tool along at least a portion of its length while it is advanced in
the direction of the insertion site,
wherein the device is configured such that its height relative to
the insertion site decreases as the tool is advanced in the
direction of the insertion site.
Such a device may further comprise a head element to which the tool
is coupled at its proximal region. In such a case, the propulsion
mechanism may include the buckling prevention mechanism and
comprise:
(i) a pair of flexible strips connected along at least part of
their length and having a central channel therebetween adapted to
receive and support the tool, the pair of strips being coupled at
its proximal region to the head element, and
(ii) a pair of rollers disposed on either side of the pair of
flexible strips, and interacting therewith such that
counter-rotation of the pair of rollers causes the pair of flexible
strips to move between the pair of rollers,
wherein upon the tool being received within the central channel,
the pair of flexible strips and the tool are connected by means of
the head element, such that counter-rotation of the rollers in an
appropriate direction pulls the pair of flexible strips and the
tool towards the pair of rollers. Each roller of the pair of
rollers may then comprise a plurality of protrusions arranged along
its circumference, the plurality of protrusions being adapted to
engage with a corresponding plurality of holes formed along the
length of each strip of the pair of flexible strips. The pair of
flexible strips may be connected on at least one side of the
central channel adapted to receive the tool. Additionally, they may
be not connected in a region of the central channel adapted to
receive the tool. Such devices with rollers may further comprise a
separating feature adapted to direct each strip of the pair of
flexible strips around one of the pair of rollers. This separating
feature may be simply the unconnected distal ends of the pair of
flexible strips, each of the unconnected distal ends being wound
around an associated roller of the pair of rollers. As an
alternative, each roller of the pair of rollers may comprise a
plurality of ridges arranged along its circumference, the ridges
being adapted to engage with corresponding ridges formed in the
pair of flexible strips.
In any of the above described devices, the central channel may
include weakened sections along its length to facilitate the
winding of each strip of the pair of flexibles strip around its
associated roller. According to different implementations, the
insertion device may comprise two separate units adapted to be
connected to and disconnected from each other, each unit
comprising:
(i) one strip of the pair of strips,
(ii) one roller of the pair of rollers, and
(iii) at least a portion of the guide member.
In yet other implementations of the above described devices, the
buckling prevention mechanism may comprise a telescopic tube. Such
a telescopic tube implementation may further comprise a head
element to which the tool is coupled at its proximal region,
wherein the telescopic tube is attached between the head element
and the guide member. In either of such cases, the device may
further comprise at least one gripping member connected to the
telescopic tube, the at least one gripping member being configured
to receive the tool and to support it as it advances in the
direction of the insertion site. The tool may be enclosed within
the telescopic tube. Furthermore, the head element may be moved
towards the guide member by means of a cable attached between the
head element and the guide member. Such a cable may be wound around
a pulley attached to the guide member.
In such devices for insertion of a tool, the propulsion mechanism
may comprise one or more piezo-electric actuators.
In any of the above described devices, the opening may further
comprise a constraining mechanism configured to be adjusted
according to the dimensions of the tool, at least a portion of the
constraining mechanism being disposed within the opening. Such a
constraining mechanism may comprise at least two portions disposed
opposite each other, and wherein at least one of the at least two
portions is adapted to be moved towards another of the at least two
portions. The constraining mechanism may then further comprise a
tightening screw.
Yet further implementations of the above described devices may
further comprise an encoder configured to determine the position of
the tool. Such an encoder may be an optical encoder configured to
determine the position of the tool by one or more of sensing
markings on the tool and sensing features on one or more components
of the buckling prevention mechanism.
Additional examples of the devices described above may comprise two
separate units adapted to be connected to and disconnected from
each other, each unit comprising:
(i) at least a portion of the guide member,
(ii) at least a portion of the propulsion mechanism, and
(iii) at least a portion of the bucking prevention mechanism.
Furthermore, the tool may comprise one or more of: a needle, a
cannula, a catheter, an introducer, a port, a fluid delivery tube
or an electrode rod.
There is further provided in accordance with an alternative
implementation of the devices of the present disclosure, an
assembly for insertion of a tool, comprising:
(i) an insertion module comprising:
(a) a guide member having an opening adapted to allow passage of
the tool therethrough, (b) a propulsion mechanism configured to
advance the tool through the opening in the direction of an
insertion site, and (c) a buckling prevention mechanism configured
to support the tool along at least a portion of its length during
its advance in the direction of the insertion site, (ii) a housing
configured to receive the insertion module, and (iii) an actuation
mechanism configured to activate the propulsion mechanism.
In such an insertion assembly, the insertion module may be
configured such that its height relative to the insertion site
decreases as the tool advances in the direction of the insertion
site. The insertion module may further comprise a head element to
which the tool is coupled at its proximal region. Furthermore, the
propulsion mechanism may include the buckling prevention mechanism
and may comprise:
(i) a pair of flexible strips connected along at least part of
their length and having a central channel therebetween adapted to
receive and support the tool, the pair of strips being coupled at
its proximal region to the head element, and
(ii) a pair of rollers disposed on either side of the pair of
flexible strips, and interacting therewith such that
counter-rotation of the pair of rollers causes the pair of flexible
strips to move between the pair of rollers,
wherein upon the tool being received within the central channel,
the pair of flexible strips and the tool are connected by means of
the head element, such that counter-rotation of the rollers in an
appropriate direction pulls the pair of flexible strips and the
tool towards the pair of rollers. In such circumstances, each
roller of the pair of rollers may comprise a plurality of
protrusions arranged along its circumference, the plurality of
protrusions being adapted to engage with a corresponding plurality
of holes formed along the length of each strip of the pair of
flexible strips. Furthermore, the distal ends of the pair of
flexible strips may be unconnected, each of the unconnected distal
ends being wound around an associated roller of the pair of
rollers.
According to different implementations, the insertion module may
comprise two separate units adapted to be connected to and
disconnected from each other, each unit comprising:
(i) one strip of the pair of strips,
(ii) one roller of the pair of rollers, and
(iii) at least a portion of the guide member.
The buckling prevention mechanism in any of the alternative
implementations of the devices of the present disclosure, may
comprise a telescopic tube, in which case the buckling prevention
mechanism may further comprise at least one gripping member
connected to the telescopic tube, the gripping member being
configured to receive the tool and to support it as it advances in
the direction of the insertion site. In these alternative
implementations too, the propulsion mechanism may comprise one or
more piezo-electric actuators. Additionally, they may further
comprise an encoder configured to determine the position of the
tool. The tool itself may comprise one or more of: a needle, a
cannula, a catheter, an introducer, a port, a fluid delivery tube
or an electrode rod. Furthermore, a first portion of the actuation
mechanism may be coupled to the housing, and a second portion of
the actuation mechanism may be coupled to the guide member of the
insertion module. In such devices, a locking mechanism may be
configured to lock the insertion module within the housing. The
locking mechanism may comprise:
(i) a rotating member coupled to the insertion module, and
(ii) one or more slits formed in the housing,
wherein rotation of the rotating member such that at least a
portion of the rotating member enters at least one of the one or
more slits, locks the insertion module within the housing.
Furthermore, in the above described insertion assemblies, the
housing may comprise one or more coupling elements adapted to
couple the housing to an automated insertion device, the automated
insertion device including at least a controller. Also, the
insertion module may comprise two separate units adapted to be
connected to and disconnected from each other, each unit
comprising:
(i) at least a portion of the guide member,
(ii) at least a portion of the propulsion mechanism, and
(iii) at least a portion of the bucking prevention mechanism.
According to yet further implementations of the devices of this
disclosure, there is provided a device for insertion of a tool,
comprising:
(i) a pair of flexible strips connected along at least part of
their length and having a central channel therebetween adapted to
receive the tool, and
(ii) a pair of rollers disposed on either side of the pair of
flexible strips, and interacting therewith such that
counter-rotation of the pair of rollers causes the pair of flexible
strips to move between the pair of rollers,
wherein upon the tool being received within the central channel,
the pair of flexible strips and the tool are secured together at an
end remote from the pair of rollers, such that counter-rotation of
the rollers in an appropriate direction pulls the pair of flexible
strips and the tool towards the pair of rollers.
In such yet further implementations, each roller of the pair of
rollers may comprise a plurality of protrusions arranged along its
circumference and adapted to engage with corresponding plurality of
holes formed along the length of each strip of the pair of flexible
strips. The pair of flexible strips may be connected on at least
one side of the central channel adapted to receive the tool, and
may be not connected in a region of the central channel. Such
devices may further comprise a holder member configured to secure
together the pair of flexible strips and the tool. They may also
have a guide member, the guide member including:
(i) one or more cavities adapted to accommodate the pair of
rollers, and
(ii) an opening adapted to allow passage of the tool
therethrough.
In that case, the opening may further comprise a constraining
mechanism configured to be adjusted according to the dimensions of
the tool, at least a portion of the constraining mechanism being
disposed within the opening. The constraining mechanism may then
comprise at least two portions disposed opposite each other, and
wherein at least one of the at least two portions is adapted to be
moved towards another of the at least two portions.
Such yet further implementations may further comprise a separating
feature adapted to direct each strip of the pair of flexible strips
around one of the pair of rollers. Such a separating feature may
comprise unconnected distal ends of the pair of flexible strips,
each of the unconnected distal ends being wound around an
associated roller of the pair of rollers. Alternatively, it may
comprise a pair of structural edges, each being disposed
sufficiently close to an associated roller that each flexible strip
is directed by one of the edges around that roller disposed close
to the edge. Alternatively, the pair of rollers may be disposed
within a guide member, and each of the structural edges are then
the edges of a component of the guide member.
In any of such yet further implementations, the central channel may
include weakened sections along its length to facilitate the
winding of each flexible strip around its associated roller.
Furthermore, the distance between two adjacent protrusions of the
plurality of protrusions may be larger than the distance between
two adjacent holes of the plurality of holes. The external surfaces
of the pair of rollers and the external surfaces of the pair of
flexible strips may alternatively be roughened such that the
interaction between them is achieved by means of friction. The tool
may comprise a tip, and the insertion device may further comprise a
protecting element configured to prevent the tip from contacting an
internal surface of the central channel as the tool is advanced in
the direction of the insertion site. The protecting element may be
inserted within the central channel, and it may comprise a hollow
tube. Alternatively and additionally, it may be coupled to at least
a portion of the insertion device externally to the central
channel. Finally, in any of these yet further implementations, the
insertion device may comprise two separate units adapted to be
connected to and disconnected from each other, each unit
comprising:
(i) one strip of the pair of strips, and
(ii) one roller of the pair of rollers.
Additionally, alternative implementations of devices of the present
disclosure may further involve an assembly for insertion of a tool,
comprising:
(i) an insertion module comprising:
(a) a pair of flexible strips connected along at least part of
their length and having a central channel therebetween adapted to
receive the tool, and (b) a pair of rollers disposed on either side
of the pair of flexible strips, and interacting therewith such that
counter-rotation of the pair of rollers causes the pair of flexible
strips to move between the pair of rollers, wherein upon the tool
being received within the central channel, the pair of flexible
strips and the tool are secured together at an end remote from the
pair of rollers, such that counter-rotation of the rollers in an
appropriate direction pulls the pair of flexible strips and the
tool towards the pair of rollers, (ii) a housing configured for
receiving the insertion module, and (iii) an actuation mechanism
configured to rotate the pair of rollers.
In such an assembly, a first portion of the actuation mechanism may
be coupled to the housing. Also, the insertion module may comprise
a second portion of the actuation mechanism. Any of such assemblies
may further comprise a locking mechanism configured to lock the
insertion module within the housing. In such a case, the locking
mechanism may comprise:
(i) a rotating member coupled to the insertion module, and
(ii) one or more slits formed in the housing,
wherein rotation of the rotating member such that at least a
portion of the rotating member enters at least one of the one or
more slits locks the insertion module within the housing.
The above described assemblies may further comprise a separating
feature adapted to direct each strip of the pair of flexible strips
around one of the pair of rollers, and that separating feature may
itself comprise unconnected distal ends of the pair of flexible
strips, each of the unconnected distal ends being wound around an
associated roller of the pair of rollers. Additionally, such
assemblies may further comprise:
(i) a front leading element coupled to the insertion module,
and
(ii) a back leading element coupled to the housing,
wherein the front and back leading elements are configured to
receive therebetween one of the unconnected ends of the pair of
strips after the one of the unconnected ends is wound around its
associated roller of the pair of rollers.
According to further implementations of such assemblies, the
housing may comprise one or more coupling elements adapted to
couple the housing to an automated insertion device, the automated
insertion device including at least a controller. Furthermore, the
insertion module may comprise two separate units adapted to be
connected to and disconnected from each other, each unit
comprising:
(i) one strip of the pair of strips, and
(ii) one roller of the pair of rollers.
Finally, according to yet another implementation of the devices of
the present disclosure, there is provided a device for insertion of
a tool, comprising:
(i) a head element to which the tool is attached at a proximal
region of the tool,
(ii) an end guide element through which the tool is delivered to an
insertion site, and
(iii) a telescopic tube attached between the head element and the
end guide element,
wherein as the telescopic tube collapses, the head element is moved
towards the end guide element and the tool advances towards the
insertion site. In such devices, the head element may be moved
towards the end guide element by means of a cable attached between
the head element and the end guide element. That cable may be wound
around a pulley attached to the end guide element. Any of these
other implementations may further comprise at least one gripping
element configured to receive the tool and to support it as it
advances in the direction of the insertion site. The tool may be
enclosed within the telescopic tube.
It is to be understood that the terms proximal and distal as used
in this disclosure have their usual meaning in the clinical arts,
namely that proximal refers to the end of a device or object
closest to the person or machine inserting or using the device or
object and remote from the patient, while distal refers to the end
of a device or object closest to the patient and remote from the
person or machine inserting or using the device or object.
It is also to be understood that although the examples used
throughout this disclosure relate to a device for insertion of a
needle, the device is not meant to be limited to use with a needle
but is understood to include insertion of any long thin tool,
medical or other, which may undergo buckling if pushed or pulled
from its proximal end without any support means, including a
needle, port, introducer, catheter (e.g., ablation catheter),
cannula, surgical tool, fluid delivery tool, or any other such
insertable tool.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be understood and appreciated more fully
from the following detailed description, taken in conjunction with
the drawings in which:
FIG. 1 shows schematically a cross-sectional view of a first
exemplary implementation of an insertion device of the present
disclosure.
FIG. 2 shows an axial cross-section view of a needle enclosed
between the two guiding strips of the insertion device of FIG.
1.
FIG. 3 is an isometric view showing schematically an implementation
of a flexible strip device with perforations running along the
length of the strips.
FIG. 4 is an isometric view showing schematically an implementation
of a flexible strip device with ridges running along the length of
the strips.
FIGS. 5A and 5B illustrate schematically an implementation in which
the motion is applied to the needle by means of piezoelectric
motors; in FIG. 5A the motors operate on the flexible strips, and
in FIG. 5B directly on the needle.
FIG. 6A illustrates schematically a further implementation of the
insertion devices of the present disclosure, in which the needle is
supported from buckling by means of a telescopic tube having
gripping clamps in each of its levels.
FIG. 6B is a close up view of the needle clamps of the device of
FIG. 6A.
FIG. 7 shows an alternative example of a telescopic tube support
device, showing a wire traction assembly for the needle head.
FIG. 8A shows a perspective view of an exemplary implementation of
the flexible strip device with perforations running along the
length of the strips of FIG. 3.
FIG. 8B shows an exemplary needle constraining mechanism.
FIG. 9 shows another perspective view of the insertion device of
FIG. 8A.
FIGS. 10A-10B are top views of two exemplary arrangements of the
rollers and the strips of the insertion device of FIG. 8A.
FIG. 11 is a cross-sectional view of operative interface between
the rollers and the strips of the insertion device of FIG. 8A.
FIGS. 12A-12C are longitudinal cross-sectional views depicting
three needle insertion stages using the needle insertion device of
FIG. 8A.
FIG. 13 shows a perspective view of an exemplary insertion assembly
comprising the insertion device of FIG. 8A coupled to a robotic end
effector.
FIG. 14 is an exploded view of the insertion assembly of FIG.
13.
FIGS. 15A-15B are perspective views of an exemplary mechanism for
securing the insertion device to the robotic end effector; in FIG.
15A the locking mechanism is in an open state; in FIG. 15B the
locking mechanism is in a closed state.
FIG. 16 shows exemplary rear and front guides for controlling the
strips' advancement direction.
FIGS. 17A-17B show perspective and longitudinal cross-sectional
views, respectively, of an exemplary strip having weakened sections
along the length of its longitudinal groove.
FIGS. 18A-18B show isometric views of an exemplary modular
insertion device in assembled (FIG. 18A) and disassembled (FIG.
18B) states.
DETAILED DESCRIPTION
Reference is first made to FIG. 1, which shows schematically a
cross-sectional view of a first exemplary implementation of the
needle insertion devices described in this disclosure. FIG. 1 shows
an insertion device 10, with a needle (or any other thin insertable
element) 100 held between a pair of flexible strips 110, of
supporting medium. The strips are held together conveniently by
means of an adhesive, welding, geometric lock mechanisms such as a
snap fit mechanism, or any other suitable attachment means, and the
needle 100 is held between the two strips 110 down a thin channel
running down the center of the coupled strips 110. The distal end
of the insertion device 10 comprises a holder 150 in which a pair
of rollers 120 are disposed. The holder 150 further includes an
opening 152 for guiding the needle 100 distally towards the
patient's body. The rollers 120 are positioned within the holder
150 such that they contact the strips 110, and as the rollers 120
counter-rotate, the double strip-needle assembly moves between the
rollers 120. The rollers 120 may be positioned within cavities
formed within the holder 150, the inner walls of the cavities being
a close fit to the outer surfaces of the rollers 120, such that as
the flexible strip-needle assembly passes between the rollers 120,
the needle 100 is able to proceed through the opening 152 beyond
the rollers 120, while each one of the flexible strips 110 is
peeled away from the needle 100 on either side of the rollers 120.
The needle then emerges from the double roller assembly bereft of
its flexible strip covering, and ready for insertion into the
patient's body. In some implementations, a "knife-edge" (not shown
in FIG. 1) or the straight corner of one of the holder elements may
be positioned such that it causes the peeling of the flexible
strips 110 away from the needle 100 and around the rollers. In
order to assist in this action, the forward (i.e., distal) ends of
the twin flexible strips 110 may be left unconnected so that each
can peel away freely around its own roller 120. The insertion
device 10 may even be supplied with each unconnected strip end
partially wound around its roller 120, or even attached thereto, or
just directed each towards a distal point on the circumference of
its roller 120, such that rotation of the rollers 120 causes the
strips 110 to peel away from the needle 100 without the need for an
"knife-edge" or the like to separate the strips 110 from each other
and from the needle 100.
The strips 110 may be paper-based or plastic-based, or made of any
other material capable of supporting the needle 100 along its
length, thereby preventing it from buckling, but at the same time
being flexible enough to curve around the rollers 120 and away from
the needle 100. Such materials may be, for example, Polyethylene
terephthalate (PET), Polyurethane (PU) or rubberized fabric. At
their proximal ends, the flexible strips 110 may be attached to the
needle head 102, or to a needle head holder 160, which encloses and
grips the needle head 102, such that as the rollers 120
counter-rotate and move the double strip-needle assembly towards
the patient's skin, the proximal end of the flexible strips 110
pulls with it the needle head 102, and thus the needle 100,
distally towards the insertion point in the patient's skin. The
propulsion of the needle 100 from its proximal end is a unique
feature which provides the needle 100 with sufficient force to
enable it to overcome any obstacles in its insertion path, whether
at the skin entry point or further down during the insertion
process.
An encoder may optionally be disposed adjacent to the strips 110,
so that the position of the strips, and hence the insertion
position of the needle 100 can be determined, such as by a
controller or a processor (not shown) receiving the output signals
of the encoder. By this means, the medical personnel are able to
track the progress of the insertion depth of the needle 100. The
encoder can be, for example, an optical encoder, which can either
count features on the strip 110, such as the strip drive holes or
ridges, as will be shown hereinbelow in FIGS. 3 and 4, or can
detect markings on the needle itself.
The insertion device 10 may be a stand-alone device, or it may be
part of an insertion assembly/system. In case the insertion device
10 is a stand-alone device, it may further comprise an actuation
mechanism, e.g., motor and gears, for rotating the rollers 120 and
thus moving the needle 100 towards (and into) the patient's body.
In the case that the insertion device is part of an insertion
assembly/system, it may be configured to be coupled to an external
actuation mechanism.
Reference is now made to FIG. 2, which is an axial cross-section
view of the two strips 110 of the insertion device of FIG. 1 and
the needle 100 enclosed therebetween. As shown, the two flexible
strips 110 are coupled together along their width, except in the
region where they envelop the needle 100 at their center line. Each
strip 110 has a groove 114 running along its centerline, providing
the strip with an "omega-like" traverse cross-section, such that
when the strips 110 are coupled together, e.g., using an adhesive,
the longitudinal grooves 114 of the two strips 110 form together a
hollow tube, or a channel, which receives and encloses the needle
100. The strips 110 may be coupled to the needle head 102 (not
shown in FIG. 2, but visible in FIG. 1) or secured to the needle
holder 160 (not shown in FIG. 2) together with the needle head
102.
As mentioned above, a number of methods are available in order to
propel the needle distally into the patient's body. Reference is
now made to FIG. 3, which is an isometric view showing
schematically a first implementation of the flexible tape device
30. In this implementation the flexible strips 310 have
perforations 312 running along at least a portion of the length of
the strips 310 and on either side of the needle position along the
centerline. As these perforations 312 engage with corresponding
protrusions (or -teeth) 322 on the rollers 320, and as the rollers
320 counter-rotate in the appropriate direction, the double
strip-needle assembly is forced in a distal direction. The proximal
ends of the strips 310 are attached to the needle head 302 and/or
to the needle head holder 360, such that as the strips 310 move
distally towards the patient's body, their proximal ends pull the
needle towards the patient. More specifically, counter-rotation of
the rollers 320 pulls downwardly the coupled strips 310 via a
"timing belt-like" mechanism comprised of the rollers' protrusions
and the strips' holes. The strips' pull forces then react with the
needle head holder 360 which pushes the needle 300 downwardly from
the needle head 302. This force can be substantially higher than
that which could be obtained if the rollers 320 were to grip the
needle 300 itself by frictional forces, and pull it down from its
distal end. As mentioned above, the entire device 30 can be a
stand-alone device or it can be part of an insertion system, e.g.,
it can be mechanically (e.g., robotically) held to align the needle
300 relative to the patient.
Reference is now made to FIG. 4, which illustrates schematically an
alternative method of locomotion for the flexible strips. In this
implementation the rollers 420 are configured as gears, and the
strips 410 are formed with ridges 415 on their outer edges and
across at least a part of their width. The ridges 415 mesh with the
teeth 425 of the rollers/gears 420, similarly to a rack and pinion
mechanism, and as the rollers/gears 420 counter-rotate, the double
strip-needle assembly is forced in a distal direction. The
attachment method of the flexible strips 410 at their proximal ends
may be the same as that described for the implementation of FIG.
3.
Although the implementations shown in FIGS. 3 and 4 provide the
double strip-needle assembly with optimum, slip-free propulsion
force, it is also possible to use conventional friction forces to
propel the assembly. In such an embodiment the surfaces of the
rollers and the external surfaces of the flexible strips have a
friction interface, such as roughened surfaces on one or on both,
so that rotation of the rollers causes the flexible strips to move
accordingly.
In order to provide sterilized operation of the device, a number of
options are available. The flexible strips may be supplied with the
needle installed as a complete sterile assembly, ready for mounting
into the roller assembly. Alternatively, the roller assembly may
also be part of the supplied device, making the entire device a
disposable one-time use device. In further embodiments, the roller
assembly, with the strips inserted thereto devoid of any needle,
may be provided as a one-time use disposable unit, such that the
user can choose the needle to be installed into the double flexible
strip guide. In such embodiments, the double flexible strip guide
may be supplied with a thin walled introducer tube down its bore,
into which the user can insert the needle, following which the
introducer tube can be withdrawn and the needle left enveloped by
the flexible strips guide. This enables the user to introduce the
needle without unintentionally scratching or puncturing the soft
material of the flexible strips, which may further result in
particles of the strips' material remaining inside the needle and
entering the patient's body.
Another solution for preventing the needle from scratching the
inner surface of the strips may be, for example, including within
the bore between the strips a short rod (i.e., shorter than the
length of the bore between the strips) with a cone-shaped head,
positioned at the top (proximal) end of the bore, the concave side
of the cone-shaped head facing the proximal end of the bore, and
thus also the incoming needle, such that when the needle is
introduced into the bore, its tip encounters the bottom of the
concave side of the cone-shaped rod head, and as the needle is
being inserted into the bore it pushes down on the cone-shape rod
head, thus pushing the entire rod downwardly until the rod falls
out from the bottom (distal) end of the bore and the needle is left
therein. Yet a further solution may be using an external
stabilizing mechanism that is coupled to the device, or at least to
the double strip-needle assembly, in order to hold it straight and
prevent the strips from folding as the needle is being inserted
into the bore, thus preventing the needle from
scratching/puncturing the strips' inner surface. Once the needle is
positioned properly within the bore between the strips, the
external stabilizing member may be removed. Such a mechanism may be
disposable and provided with the device, i.e., pre-assembled, and
discarded after a single use.
Reference is now made to FIGS. 5A and 5B, which illustrate
schematically an implementation in which the motion is applied to
the needle by means of piezoelectric motors. In FIG. 5A, the
piezoelectric motors 530 are situated on either side of the
flexible strips 510, such that as they are activated, their driver
legs 535 move the strips 510 with the encased needle 500 distally
towards the patient's body. In this implementation, the rollers 520
need not take part in the propulsion, and can function just in
order to guide the flexible strips 510 so that they are peeled away
from the needle 500. FIG. 5B shows a similar implementation except
that no flexible strip is used, and the piezoelectric motors 530
operate directly on the needle 500.
Reference is now made to FIGS. 6A to 7, which illustrate
schematically further implementations of the insertion device of
the present disclosure, in which the needle is supported from
buckling by means of a telescopic tube which provides support along
the length of the needle. However unlike prior art telescopic
support systems, these implementations enable the height of the
device to be reduced as the needle is inserted, such that they are
more convenient for use in limited space situations, such as in the
bore of a CT system. The needle is attached to a holder element at
its proximal end, and to a needle guide at its distal end to align
the correct insertion point of the needle. The telescopic tube
assembly is attached between the holder element and the end guide
to provide support to the needle as it is pushed (or pulled) into
the patient by means of a force applied to the holder element.
FIG. 6A shows an insertion device 60 having a telescopic tube 610
attached to the needle 600 by means of clamps 620, which allow the
needle to slide through them. As the holder element 660, to which
the needle is attached, is pushed (or pulled) distally to insert
the needle 600 into the patient's body, the telescopic tube 610,
which is connected between the holder element 660 and the distal
end guide 640 of the device, collapses, enabling the holder 660 to
approach the distal end guide 640 as the needle 600 is inserted.
The holder element 660 may be pushed down manually or it may be
pushed or pulled down using various propulsion mechanisms, such as
a pulley wheel and a cable, as shown below in FIG. 7. In some
implementations, the needle 600 is not externally attached to the
telescopic tube 610, but encapsulated therein.
Reference is now made to FIG. 6B, which is a close up view of the
clamps 620 of the device shown in FIG. 6A, showing how the needle
600 can slide through the openings in the clamps 620 as the
telescopic tube 610 collapses upon itself, as shown in region 650
of the telescopic tube assembly.
Reference is now made to FIG. 7, which shows a further exemplary
implementation of the telescopic tube support devices shown in
FIGS. 6A and 6B, showing an insertion device 70 in which the motion
of the needle 700 is achieved by means of a cable 720 attached to
the needle head holder 760, and passed around a pulley wheel 730 at
the distal end of the telescopic tube 710, and pulled manually or
by means of a motor, a hydraulic/pneumatic piston or any other
suitable actuation/propulsion mechanism (not shown). By means of
such a configuration, needle motion can be obtained by means of a
mechanism whose length collapses together with the telescopic
support guide 60, thereby overcoming the above mentioned problem of
how to perform needle insertion in limited spaces, where the length
of a conventional lead screw drive mechanism connected between the
needle head and the distal end, for example, as described in the
abovementioned U.S. Pat. No. 7,822,458, would interfere with this
aim.
Reference is now made to FIGS. 8A-11C, which show an exemplary
implementation of the insertion device shown in FIG. 3, i.e., a
flexible strip device with perforations running along the length of
the strips. In this implementation, the insertion device (which may
also be referred to as "insertion module") is configured as part of
an insertion assembly, which is configured for coupling to an
automated insertion system (e.g., a robotic system). Such an
automated insertion system may be body-mounted or may be configured
for coupling to a dedicated arm connected to the patient's bed or
to the imaging device (e.g., CT, MRI), if the procedure is
image-guided.
FIG. 8A shows a perspective view of an insertion module 80
comprising a needle (or any other insertable tool, such as an
introducer, a catheter, etc.) 800 enclosed within a channel formed
by two flexible strips 810a, 810b coupled together. In some
implementations, the needle 800 is provided together with the
insertion module 80, i.e., as an integral component of the
insertion module, whereas in other implementations, the insertion
module is configured to receive a variety of different commercially
available needle types, and the needle is chosen and introduced
into the insertion module by the user (e.g., nurse, physician)
prior to initiating the insertion procedure.
The flexible strips 810a, 810b have perforations (or -holes) 812
running along at least a portion of their length, and a groove
814a, 814b running along their longitudinal centerline, such that
when the strips are attached to each other their coupled grooves
814a, 814b form together the channel that receives and encloses the
needle 800.
In some implementations, each strip 810a, 810b may include four
rows of perforations 812, e.g., two rows on each side of the groove
814a, 814b, as shown in FIG. 8A. In other implementations, each
strip 810a, 810b may include two rows of perforations 812, one row
on each side of the groove 814a, 814b, as shown below in FIG. 9B.
It can be appreciated that the arrangement of the perforations is
not limited to two or four rows, and the strips may include any
number of perforation rows or any other applicable perforation
arrangement.
The insertion module 80 further comprises two rollers 820a, 820b
having protrusions 822 thereon. The protrusions 822 are aligned
with the perforations 812 of the strips 810a, 810b, such that as
each roller 820a, 820b rotates, its protrusions 822 engage the
perforations 812 of the corresponding strip 810a, 810b, resulting
in the strips 810a, 810b being pulled down and around the rollers
820a, 820b.
The insertion module 80 may further include a bevel gear 830
mounted on the same shaft 840a as one of the rollers, in this case
roller 820a, such that rotation of the bevel gear 830 causes roller
820a to rotate in the same direction. Counter-rotation of the
second roller 820b is achieved via two gears mounted at the
opposite end of the shafts 840a, 840b, as described below in FIG.
8B.
The shafts 840a, 840b, and the rollers 820a, 820b may be enclosed
within a holder 850, which may include a shaft (or -axes) holder
portion 853, a strip guide portion 855 and a needle guide portion
857. The shaft holder portion 853 is configured to hold and secure
the position of the shafts 840a, 840b. The strip guide portion 855
is configured to lead the strips away from the rollers as the
rollers continue to rotate, and its walls may include slits 8552
that allow passage for the protrusions 822 as the rollers rotate.
The needle guide portion 857 may include an elongated "tube-like"
opening (not shown in FIG. 8A), which is configured to receive the
needle 800 as it is pulled (or pushed) in the distal direction and
the strips 810 are peeled away from the needle 800. The needle
guide portion 857 also confines the needle 800 to the elongated
opening and thus guides the needle 800 in the desired direction of
insertion.
In some implementations, in order for the insertion module 80 to be
used with a variety of needle types and sizes, the elongated
opening may have a diameter that is equal or slightly larger than
that of the needle with the largest diameter (gauge) intended for
use with the insertion module 80. In other implementations, the
elongated opening may include therewithin a constraining mechanism,
which can be adjusted according to the diameter of the needle being
used. An exemplary constraining mechanism is shown in FIG. 8B,
which is a transverse cross-sectional view of the mechanism. The
constraining mechanism may include a stationary portion 8572, which
is fixedly connected to the inner surface 8573 of the needle guide
portion 857 of the holder 850, and a moveable portion 8574. The
moveable portion 8574 may be connected to a screw (or -bolt) 8576
whose head is positioned outside the needle guide portion 857 so
that it is accessible to the user. The bolt 8578 may be coupled to
a stationary nut 8578, such that rotation of the bolt 8576 results
in linear movement of the moveable portion 8574. In some
implementations, the stationary and moveable portions may each
comprise a block with two triangular edges 8571, 8575 respectively,
forming therebetween a v-groove 8573, 8577 respectively, and as the
moveable portion 8574 advances towards the stationary portion 8572
the triangular edges 8575 of the moveable portion 8574 fit beneath
the block of the stationary portion 8572, as shown in FIG. 8B, or
vice versa. In other implementations, the stationary and moveable
portions may each comprise a plurality of such blocks and the
triangular edges 8571, 8575 intertwine as the moveable portion 8574
advances towards the stationary portion 8572. Thus, after a needle
800 is inserted into the insertion module, the user rotates the
bolt 8576 in the appropriate direction such that the moveable
portion 8574 advances towards the stationary portion 8572 until
there is contact between the needle 800 and the two v-grooves 8573,
8577 and the needle 800 is tangent to each of the triangular edges
8571, 8575 along a single line 8579 (shown as a dot in FIG. 8B). It
can be appreciated that the constraining mechanism may include
instead of the bolt 8576, or in addition to the bolt, a spring (not
shown), or any other element suitable for moving/pushing the
moveable portion 8574 towards the stationary portion 8572.
The axes holder portion 853, strip guide portion 855 and needle
guide portion 857 may be three separate components assembled
together to form the holder 850, or they may be manufactured as a
single unit. In some implementations two of the three portions
(e.g., the strip guide and needle guide portions) may be
manufactured as one component, which is then coupled to the third
portion (e.g., the axes holder portion).
The insertion module 80 may further include a needle head holder
860, which secures together the needle head 802 and the proximal
end of the strips 810a, 810b. In some implementations, the needle
head holder 860 may be composed of two portions 862 which are
coupled together after the needle 800 is inserted into the channel
between the two strips 810a, 810b, e.g., using screws, an adhesive
or a latch mechanism. In some implementations, the two portions 862
of the needle head holder 860 may be fixedly secured together at
their distal end, to which the proximal ends of the strips 810a,
810b are attached, and after the needle 800 is inserted into the
channel between the two strips, the proximal (top) ends of the two
portions 862 are joined together over the needle head 802. If
intended for use in the medical field, the insertion module 80
should be a disposable single-use device, in order to prevent
cross-contamination between patients. Thus, in some
implementations, in order to ensure that the insertion module 80 is
not reused with a new needle, the needle head holder 860 may be
configured such that once it is fastened over the needle head 802,
it cannot be removed from the needle head 802, or that removing the
needle head holder 860 from the needle head 802 causes permanent
damage to the needle head holder 860 such that it loses its
functionality.
FIG. 9 shows another perspective view of the insertion module 80.
As described above, the insertion module 80 may include a bevel
gear (not shown in FIG. 9), which in this implementation is mounted
on shaft 840a of roller 820a. Thus, rotation of the bevel gear 830
causes roller 820a to rotate in the same direction. The insertion
module 80 further includes two gears 870a, 870b which are mounted
on the roller shafts 840a, 840b respectively. The gear 870a is
mounted on shaft 840a at the end opposite the end at which the
bevel gear is mounted, such that rotation of the bevel gear causes
rotation of the gear 870a in the same direction as the bevel gear
and roller 820a. The teeth of the gear 870a mesh with the teeth of
the gear 870b, causing the gear 870b to rotate in the direction
opposite that of the gear 870a. Since the roller 820b is mounted on
the same shaft 840b as the gear 870b, rotation of the gear 870b
results in rotation of the roller 820b in the same direction as the
gear 870b, i.e., in the opposite direction of the roller 820a. As
the rollers 820a, 820b counter-rotate, their protrusions 822 engage
the strips' perforations 812, such that the strips 810a, 810b,
together with the enclosed needle 800, are pulled in the distal
direction towards the patient's body. The strips 810a, 810b are
then forcefully separated from one another, pulled in opposite
directions and around the rollers 820a, 820b, while the needle 800
continues its translation in the distal direction and into the body
of the patient.
In some implementations at least one of the gears 870a, 870b may be
a ratchet gear, provided with a pawl, so that the gears can only
rotate in one direction, while synchronizing or meshing the
rotation of the rollers 8201, 820b. Use of a ratchet gear prevents
re-use of the insertion module 80, which after one use is no longer
sterile, with a new needle. It can be appreciated that the
insertion module 80 may include other mechanisms to prevent its
re-use, such as a non-removable needle head holder, as described
above.
FIG. 10A is a top view of the insertion module 80, without the
needle and the needle head holder, showing an exemplary arrangement
of the rollers 820a, 820b within the holder 850 (not shown in FIG.
10A). In this implementation, in order to avoid the risk of the
protrusions 822 of the two rollers bumping into each other as the
rollers counter-rotate, which may interrupt the insertion procedure
or even cause damage to the strips or the needle, etc., the rollers
820a, 820b are positioned in opposite directions relative to each
other, such that the protrusions of each roller do not face the
protrusions of the other roller. Further, the protrusions 822 are
disposed circumferentially around each roller, such that each
roller 820a, 820b includes two "rings" of protrusions 822. In this
implementation, opposite each such "ring" there is an annular
groove 824 on the other roller, which allows uninterrupted passage
of the protrusions 822 as the rollers 820a, 820b counter-rotate.
Since the protrusions 822 do not face each other, the strips 810 in
this implementation are provided with four rows of perforations
812, one row corresponding to each of the four protrusion
"rings".
In some implementations, each roller 820a, 820b further includes an
additional annular groove 826, which may be wider and deeper than
the annular grooves 824, and disposed in the transverse center of
the roller, in order to allow uninterrupted passage of the convex
side of the grooves 814a, 814b running down the longitudinal center
of the strips 810a, 810b, as the strips move in the distal
direction and around the rollers 820a, 820b. When the strips 810a,
810b are attached (e.g., adhered) to each other, the longitudinal
grooves 814a, 814b form together the channel 815 which receives and
accommodates the needle therein. In some implementations, instead
of the insertion module 80 including two rollers 820a, 820b each
having an annular center groove 826, the insertion module 80 may
include four rollers, each pair of rollers disposed on a single
shaft, and spaced apart so as to allow uninterrupted passage of the
convex side of the grooves 814a, 814b therebetween.
FIG. 10B is a top view showing an alternative arrangement of
rollers 920a, 920b within the holder (not shown in FIG. 10B) of
another exemplary insertion module 90. In this implementation, the
rollers 920a, 920b are spaced apart slightly further than the
rollers 820a, 820b of FIG. 10A, such that the protrusions 922 of
the two rollers 920a, 920b can be disposed on the rollers such that
they face each other without there being a risk of the protrusions
of the two rollers 920a, 920b bumping into each other as the
rollers counter-rotate. Accordingly, in this implementation each
strip 910a, 910b has only two rows of perforations 912, one row on
each side of the annular groove 914a, 914b.
It can be appreciated that, similarly to the implementation shown
in FIG. 10A, in this implementation as well the insertion module 90
may include, instead of two rollers 920a, 920b each having an
annular center groove 926, four rollers mounted two on each of the
shafts 940a, 940b.
As further shown in FIG. 10B, in some implementations the bevel
gear 930, the rotation of which results in rotation of the rollers
920a, 920b, may be mounted on shaft 940b.
Reference is now made to FIG. 11, which is a cross-sectional view
showing the protrusions 822 of the roller 820b as they engage the
perforations 812 of strip 810b. As described above, in some
implementations the protrusions of the two rollers 820a, 820b do
not face each other, i.e., they are disposed in an offset relative
to each other. Accordingly, the cross-sectional view of FIG. 11
depicts only the protrusions of roller 820b as they engage the
perforations of strip 810b, and the interface between the
protrusions of roller 820a and the perforations of strip 810a
cannot be seen. However, it can be appreciated, that the
description below regarding the interface between the protrusions
of roller 820b and the perforations of strip 810b applies equally
to the interface between the protrusions of roller 820a and the
perforations of strip 810a.
In some implementations the pitch of the roller 820b may be
slightly larger than the pitch of the strips 810b, i.e., the
distance between two adjacent roller protrusions may be larger than
the distance between two adjacent strip perforations. As a result,
the load of pulling the strip falls on the last protrusion 822a
that remains engaged with the strip 810b before the strip
disengages from the roller 820b. This is advantageous since it
ensures that the strip 810b remains tightly coupled to the roller
820b in the section between the first engaging protrusion 822b and
the last engaging protrusion 822a, as the roller 820b rotates. If
the distance between two adjacent protrusions 822 was smaller than
the distance between two adjacent perforations 812, the load of
pulling the strip 810 would fall on the first protrusion 822b that
engages the strip 810b as the roller 820b rotates. This might
result in the strip 810b disengaging from the roller 822b as it
rotates and falling onto the internal surface of the holder 850,
which may result in high friction or even damage to the strip
and/or roller and interruption of the insertion procedure. Further,
the friction forces may increase in case the strip 810b includes an
adhesive on its internal surface for attachment to the second strip
810a, since the remains of the adhesive might cause the strip 810b
to attach to the internal surface of the holder 850 after the
strips are separated from each other.
Reference is now made to FIGS. 12A-12C which show longitudinal
cross-sectional views of the insertion device 80 illustrating three
different stages of the needle insertion procedure.
FIG. 12A shows the insertion device 80 at its initial state, i.e.,
prior to initiation of the insertion procedure. In the shown
embodiment, the device is supplied with the distal end of the
strips 810a, 810b already wound around the rollers 820a, 820b
respectively so as to ensure that the strips detach from one
another and roll outwardly and away from each other, together with
the counter-rotating rollers 820a, 820b. In some implementations,
prior to commencement of the insertion procedure, the tip of the
needle 800 is substantially aligned with the distal (bottom) end of
the holder 850. In other implementations the needle tip may be
slightly concealed within the holder 850 or it may slightly
protrude therefrom. FIG. 12B shows the insertion device 80 after
the needle 800 has been partially inserted into the patient's body,
and the strips 810a, 810b have peeled further away from the needle
800 and around the rollers 820a, 820b.
FIG. 12C shows the insertion device 80 at an advanced stage of the
insertion process. The needle head holder 860 is now nearing the
holder 850 and the rollers 820a, 820b and the strips 810a, 810b are
further peeled off the needle 800 and wound around the rollers
820a, 820b.
Reference is now made to FIG. 13, which shows a perspective view of
an insertion assembly 5 comprising the insertion module 80 coupled
to a robotic end effector 1300. The end effector 1300 includes a
frame (or -housing) 1310 for receiving and housing the insertion
module 80, and a motor assembly 1320, which includes a geared motor
1322 (i.e., motor and planetary gear system) provided with a motor
encoder (not shown) for verifying proper function of the geared
motor 1322, a bevel gear 1324, and a Printed Circuit Board (PCB)
1326. After the insertion module 80 is coupled to the end effector
1300, it may be secured to the end effector 1300 using one or more
screws 1330, or any other suitable securing mechanism, such as the
mechanism shown hereinafter in FIGS. 15A-15B.
In some implementations, the insertion module 80 is a disposable
single-use unit, and the end effector 1300 is reusable, i.e., it
can be used repeatedly with new disposable insertion modules 80. In
such cases the end effector 1300 is preferably an integral unit of
an automated (e.g., robotic) insertion device (not shown in FIG.
13). In other implementations the end effector 1300 may be
disposable and separate from the automated insertion device. In
such cases the end effector 1300 and the insertion module 80 may be
manufactured as a single unit.
In some implementations, the motor assembly 1320 is an integral
component of the end effector 1300. In other implementations, the
motor assembly 1320 may be separate from the end effector 1300 such
that it is coupled to the end effector 1300 either before or after
the insertion module 80 is coupled to the end effector 1300. The
motor assembly 1320 actuates the insertion mechanism as follows:
the geared motor 1322 rotates the bevel gear 1324, which in turn
rotates the bevel gear 830 of the insertion module 80, to which it
is coupled. The bevel gear 830 of the insertion module 80 then
rotates the rollers (not shown in FIG. 13) of the insertion module
80, as described above with regard to FIGS. 8A and 9. It can be
appreciated that any other applicable method of transferring moment
from the motor assembly 1320 to the insertion module 80 may be
implemented, and using coupled bevel gears 830 and 1324 is merely
one exemplary method.
In case the motor assembly 1320 is an integral part of the end
effector 1300, the motor assembly 1320 may be connected to the
frame 1310 such that the motor assembly 1320 can be moved aside in
order to allow proper coupling (and de-coupling) of the insertion
module 80 to the end effector 1300. For example, the interface
between the motor assembly 1320 and the frame 1310 may be in the
form of a hinge, such that the motor assembly 1320 can pivot about
its axis. After the insertion module 80 is introduced into the
frame 1310, the motor assembly 1320 is moved back to its position
such that the bevel gear 1324 is properly coupled to the bevel gear
830 of the insertion module 80. The motor assembly 1320 may be
moved back to its position either manually or automatically, e.g.,
the motor assembly 1320 may include a projection (not shown) which
is pressed (or otherwise engaged) by the insertion module 80 as it
is being inserted into the frame 1310 of the end effector 1300,
such that coupling the insertion module 80 to the end effector 1300
causes the motor assembly 1320 to return to its place and establish
operative coupling with the insertion module 80 (e.g., between
bevel gear 830 of the insertion module and bevel gear 1324 of the
motor assembly 1320).
FIG. 14 shows an exploded view of the insertion assembly 5 of FIG.
13. Shown are the insertion module 80 with the two portions 862 of
the needle head holder 860, which when connected by means of a
plurality of screws 864, for example, secure together the needle
head 802 and the proximal end of the strips 810a, 810b. Also shown
is the end effector 1300 comprising the end effector frame 1310 and
the motor assembly 1320. As previously discussed, the insertion
module 80 is coupled to the end effector 1300 by inserting the
insertion module 80 into the end effector frame 1310, and locking
it therein by means of two screws 1330, for example. The end
effector frame 1310 may include a dedicated slot 1312 for receiving
the shaft 840a such that the bevel gear 830 remains outside the
frame 1310 after the insertion module 80 is inserted into the frame
1310, to enable its coupling to the bevel gear 1324 of the motor
assembly 1320.
FIGS. 15A-15B show an alternative mechanism for locking the
insertion module 80 within the frame 1310 of the end effector 1300.
In some implementations, the insertion module's holder 850, or more
specifically, the needle guide portion 857 of the holder, may
include a rotatable element 858 including two blades 8582 (which
may be manufactured as a single long blade), and a knob 8584 which
can be grasped by the user. The end effector frame 1310 may have
two slits 1315, opposite one another, such that the blades 8582 can
enter the slits 1315 when the rotatable element 858 is rotated via
the knob 8584. When the rotatable element 858 is in a vertical
position, i.e., the blades 8582 are parallel to the needle 800, as
shown in FIG. 15A, the insertion module 80 can be moved freely in
and out of the end effector frame 1310. When the rotatable element
858 is rotated into a substantially horizontal position, i.e., 90
degrees (or slightly less/more) to the right or to the left, the
blades 8582 enter the slits 1315, as shown in FIG. 14B, and the
insertion module 80 is locked in its place within the frame 1310
such that it cannot be removed from the end effector 1300 by mere
pulling.
FIG. 16 shows the insertion module 80 inserted within the end
effector frame 1310. As described above, as the rollers 820a, 820b
counter-rotate, the protrusions of the rollers engage the
perforations of the strips, which causes the strips 810a, 810b to
peel off the needle 800 in opposite directions, around the rollers
820a, 820b, and then exit the insertion module's holder 850. In
some implementations, the interface between the insertion assembly
5 and the automated insertion device (not shown) may be such that
as the strips 810a, 810b exit the holder 850 and fold outwardly, at
least one of the strips, e.g., strip 810a, might contact other
components of the automated insertion device, such as a joint (not
shown) connecting the end effector to the automated insertion
device, which may interfere with its proper function. Thus, in some
implementations the frame 1310 of the end effector 1300 may include
a back guide 1318 and the insertion module 80 may include a front
guide 880 coupled to the holder 850, that together prevent the
strip 810a from folding outwardly toward the automated insertion
device by constraining the strip 810a to the space between them. In
some implementations, there may be provided only a back guide 1318
without a front guide 880.
FIG. 17A shows a perspective view of an exemplary strip 1710. As
previously discussed, as the rollers counter-rotate, the
protrusions of the rollers engage the perforations of the strips,
resulting in the strips, with the needle enclosed therebetween,
being pulled in the distal direction, while the strips detach from
each other and peel off the needle in opposite directions and
around the rollers. Since the strips 1710 are not flat but have a
groove 1714 running along their length, with the convex side of the
groove facing the roller, causing the strips to detach from each
other and curve outwardly as they are being pulled by the rotating
rollers requires a significant amount of energy, which can only be
provided by a powerful and relatively large propulsion mechanism
(e.g., motor and gears, piston, etc.). Thus, in order to reduce the
amount of energy required to detach the strips from each other and
cause them to curve outwardly and wind around the rollers, the
strips' groove 1714 may include weakened sections 1716 along its
length, which facilitate the curving action of the strips without
diminishing the strength of the strips 1710. Preferably, the
weakened sections 1716 should be spaced apart according to the
natural plastic deformation pattern of the strip 1710, as
determined empirically. FIG. 17B is a longitudinal cross-sectional
view of the groove 1714 of strip 1710, showing the wave-like
profile of the groove 1714 having weakened areas 1716, in this case
equally spaced weakened areas 1716.
Once the medical tool (e.g., needle) is inserted into its desired
position within the patient's body, the physician/clinician may
prefer to remove the insertion device/assembly and the entire
automated insertion system (when a body-mounted insertion system is
employed) from the patient's body, leaving only the tool in its
place. For example, during biopsies in which an introducer is
inserted into the patient's body using the insertion device, once
the introducer is in its position, the core of the introducer is
removed from the introducer and a biopsy needle is inserted through
the introducer and into the target (e.g., tumor). In such cases,
the insertion device and/or the automated insertion device may
obstruct the clinician's view or actions such that he/she may
prefer to remove all devices/components other than the introducer
from the patient's body.
FIG. 18A shows an isometric view of an exemplary modular insertion
device/module 180 in its assembled state. The insertion module
comprises two parts 182, 184 connected along their longitudinal
axis. Each part 182, 184 includes one portion of the holder 1852,
1854, one strip 1810a, 1810b, one roller (not shown) and one gear
1872, 1874 (all numerals respectively). In the initial situation
for inserting the needle, with the two parts 182, 184 connected,
the strips 1810a, 1810b, in the region before being fed to the
rollers, are attached to each other or held together, and their
coupled grooves 1814a, 1814b together form the channel that
receives and encloses the needle 1800.
FIG. 18B shows an isometric view of the exemplary modular insertion
device/module 180 in its disassembled state. One of the parts, e.g.
part 182, may have a plurality of protrusions 1882, and the second
part, e.g. part 184, may have a plurality of corresponding
slots/niches 1884 (only one slot/niche 1884 is visible in FIG. 18B)
for receiving the protrusions 1882 when the two parts 182, 184 are
connected. It can be appreciated that any other suitable method for
connecting the two parts of the insertion module may be
implemented. Since the needle 1800 is enclosed within the channel
formed between the strips 1810a, 1810b, but it is not connected to
the strips 1810, 1810b, or to any other component of the insertion
module 180, once the needle 1800 has reached its target, the user
can disconnect the two parts 182, 184 from one another, thus
detaching the strips 1810a, 1810b from one another and away from
the needle 1800, without applying on the needle 1800 any major
forces which may cause it to move from its position.
It is appreciated by persons skilled in the art that the present
invention is not limited by what has been particularly shown and
described hereinabove. Rather the scope of the present invention
includes both combinations and subcombinations of various features
described hereinabove as well as variations and modifications
thereto which would occur to a person of skill in the art upon
reading the above description and which are not in the prior
art.
* * * * *